NCT06582212 Enabling Women with Parkinson's Disease to Identify and Better Manage Hormonal Triggers of Parkinsonian Symptoms
| NCT ID | NCT06582212 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Grenoble |
| Condition | Digital Technology |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-03-12 |
| Primary Completion | 2027-03-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-03-12 with a primary completion date of 2027-03-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Forty percent of people living worldwide with Parkinson's disease (PD) are women. Twenty percent of patients have PD onset under the age of 60 years, a time when women may encounter significant caregiving responsibilities along with occupational and other competing demands. Studies with surveys of women with PD (WwPD) have reported worsening of PDrelated symptoms especially in the week prior and the week of menses. However, prospective evidence is scarce and clinical guidelines to manage this issue do not exist. As a result, care is either non-existent or fragmented. The investigators propose a French multicentre prospective pilot study to capture changes in PD symptoms in relation to the stages of the menstrual cycle aiming at reducing hormonal related worsening in PD symptoms through neurologist intervention and/or patient selfmanagement. Digital technology will remotely enable patient reported outcome (PRO) tracking through the My Moves Matter app changes in PD symptoms during several months. This information will then help neurologists to customize treatment. Changes in motor symptoms will also be highlighted by tracking through the use of a wearable device (PDMonitor) to objectively detect motor changes together with the app. This will further support the reliability of the app. This study will provide evidence for the impact of the menstrual cycle on PD and help neurologists and patients to better manage PD symptoms related to these hormonal changes.
Eligibility Criteria
Inclusion Criteria: * Non-menopausal women * Diagnosis of PD according to the MDS criteria onset of PD symptoms since at least two years before inclusion * Age 18-56 years * On stable medication regimen for PD for at least two months without foreseen need to modify it within the next three months * With and without OCP or intrauterine devices (IUD Exclusion Criteria: * Post-menopausal women with PD * Any condition that, in the opinion of the investigator, will preclude the participant from successfully or safely completing study procedures (i.e., dementia, severe depression, etc.) * People not able to give an informed consent.
Contact & Investigator
Elena MORO
PRINCIPAL INVESTIGATOR
CHU Grenoble Alpes
Frequently Asked Questions
Who can join the NCT06582212 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 56 Years, studying Digital Technology. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06582212 currently recruiting?
Yes, NCT06582212 is actively recruiting participants. Contact the research team at emoro@chu-grenoble.fr for enrollment information.
Where is the NCT06582212 trial being conducted?
This trial is being conducted at Grenoble, France, Nantes, France, Rennes, France, Toulouse, France.
Who is sponsoring the NCT06582212 clinical trial?
NCT06582212 is sponsored by University Hospital, Grenoble. The principal investigator is Elena MORO at CHU Grenoble Alpes. The trial plans to enroll 100 participants.